Eisai's new breast cancer drug Halaven hits UK shores

UK patients suffering from advanced breast cancer have gained a new treatment option after Japanese drugmaker Eisai launched its marine-based drug Halaven onto the market.

Halaven (eribulin) was given a green light by European regulators last month for patients with locally advanced breast cancer whose disease has progressed after at least two chemotherapy regimens (including an anthracycline and a taxane unless unsuitable).

Breast cancer is the most common cancer in the UK, accounting for about 16% of female cancer deaths. Thirty percent of women diagnosed with early or localised breast cancer will go on to develop metastatic or advanced disease, for which treatment options are somewhat limited.

Halaven's emergence on the market has caused quite a buzz among clinicians given that, according to Eisai, it is the first single-agent therapy to show a significant overall survival benefit in patients with advanced stage diseae.

It's approval was based on data from a Phase III clincial trial (EMBRACE), which compared overall survival those given Halaven versus a Treatment of Physician’s Choice (TPC; any single-agent chemotherapy, hormonal treatment or biologic therapy approved for the treatment of cancer; or palliative treatment or radiotherapy administered according to local practice).

Survival benefit

The study involved 762 patients with metastatic breast cancer, previously treated with at least two and a maximum of five prior chemotherapies, and found that median overall survival the Halaven group was 13.2 months versus 10.5 months for the TPC arm, clearly showing a survival benefit.

According to consultant medical oncologist Andrew Wardley, Halaven "addresses an urgent need for new treatment options for women with advanced breast cancer who have previously received multiple treatments".

While the drug is currently only licensed for advanced breast cancer, its potential in earlier stages of the disease is currently being assessed in a study pitting it against Roche's chemotherapy Xeloda (capecitabine). Results are expected something in the next year, and if positive could substantialy widen the number of patients eligible for treatment.